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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceQuantiferon TB Gold
Generic NameTEST, IMMUNITY, CELL MEDIATED, MYCOBACTERIUM TUBERCULOSIS
ApplicantQIAGEN
19300 Germantown Road
Germantown, MD 20874
PMA NumberP010033
Supplement NumberS034
Date Received05/24/2017
Decision Date06/20/2017
Product Code NCD 
Advisory Committee Microbiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Add an in-house facility as an additional site for Quality Control testing for components.
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